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Outsourcing your research requirements has become quite essential for every biopharmaceutical company if they intend to stay ahead in the market competition today. Bioanalytical CROs or the contract research organizations helps the biopharmaceutical industries in … Read More
Outsourcing your research requirements has become quite essential for every biopharmaceutical company if they intend to stay ahead in the market competition today. Bioanalytical CROs or the contract research organizations helps the biopharmaceutical industries in managing their drug discovery and development process. Possessing an ample of expertise in both the pre-clinical and clinical frontiers of the research and development, CROs worldwide are functioning as key enablers as well as the strategic partners for completing their drug development pathways.
CROs are independent organizations or the service providers participating in the drug discovery and development process. They make sure to provide a wide range of the bioanalytical lab services to the pharmaceutical, medical device, and biotechnology industries. Such services encompasses all the critical phases involved in the process of the drug discovery and development.
With the challenging situations of the pharmaceutical sector, the CRO industry has also been growing tremendously. It has greatly acquired benefits across the recent downsizing trends along with the combination of growing R&D pipelines. Outsourcing their research and development requirement to CROs permits smaller companies for effectively managing their drug discovery and development programs with the availability of minimal infrastructure.
The way in which the biopharmaceutical companies connect with CROs is also changing tremendously. What was once believed to be driven either by functional or tactical outsourcing, now, CROs are taking lead as much larger and complex part of the pharmaceutical industries. For the pharma clients worldwide, CROs have become strategic partners to base their enabling technologies or the strategic business model that generates higher quality or are backed with much efficient research and development execution.
Bioanalytical laboratory services are involved in the organization and management of the clinical studies right from phase 1 to phase 3 thereby securing monitoring of the clinical trials to deliver much required information which is essential to seeking timely approval. Pre-clinical CROs helps in testing potent drug or device candidate for their client businesses even before the start of their clinical analysis. This might possibly help their client organizations in synthesizing compounds, run biochemical assays and conduct subsequent preclinical (animal) and clinical (human) trials.
The prime facie of the CROs industries today is focusing their attention to several aspects of clinical trial services such as regulatory submissions, medical writings, projects monitoring and management, data analysis and management. Larger CROs usually provide their clinical services to the pharma giants.
The best CROs in the run provides a plethora of services such as method development, assessing its feasibility and validation; GLP and GCP based sample analysis; non-GLP sample analysis; non-clinical bioanalysis; etc. An efficient CRO should possess and deliver capabilities for designing and performing a variety of bioanalytical assays facilitating a range of clinical and non-clinical studies. These are inclusive of both the in-vivo and in-vitro analysis for supporting various drug discovery and development programs.
Possesses an in-house expertise team with extensive capabilities for handling complexed bioanalysis
Developing efficient procedures and methods for ensuring support of high quality data indicating different crucial aspects of the drug development process
Developing comprehensive SOPs for accomplishing bioanalysis of the pharmaceutical products thereby ensuring compliance with both the GCP and GLP standards and other regulatory compliances.